PDA members advancing knowledge through research

March 1, 2005

Rio de Janeiro, Brazil — A review of literature pertaining to cutaneous pigmentary disorders reveals that, historically, the field has been vastly under-explored, especially considering the high prevalence of pigmentary disorders worldwide and their devastating toll on quality of life.

Rio de Janeiro, Brazil - A review of literature pertaining to cutaneous pigmentary disorders reveals that, historically, the field has been vastly under-explored, especially considering the high prevalence of pigmentary disorders worldwide and their devastating toll on quality of life.

While the Pigmentary Disorders Academy (PDA) aims, as a group, to address the informational gaps in this area and the need for high-quality clinical trials, its members are also actively pursuing their own basic science and clinical research interests to advance knowledge on disease pathogenesis, epidemiology and care. At the second annual meeting of the PDA, members shared information with their colleagues about some of their latest investigations.

Ethnic implications A major objective of the agenda at this year's PDA meeting was the consideration of ethnicity-related issues in the treatment of Latin American patients with hyperpigmentation. The projects of several PDA members coincide with that focus.

"We expect that by gaining better insight into the factors that trigger melasma, we may find interesting correlations for improving intervention," Dr. Hexsel says.

Tania Cestari, M.D., associate professor of dermatology, University of Rio Grande do Sul School of Medicine, Porto Alegre, describes a project she has been involved in to develop a Portuguese translation of the Melasma Quality of Life scale that would be culturally valid for use in a Brazilian population. The translation was performed according to rules from the World Health Organization, was tested in a patient sample and was revised based on the feedback obtained.

"This was a very time-consuming task, but it was an important project and something that must be done if we wish to explore quality of life in melasma patients on an international basis using a disease-specific instrument," Dr. Cestari says.

Similarly stressing the importance of measuring the impact of skin conditions and their treatment on quality of life, Ivonne Arellano, M.D., coordinator, dermatologic surgery department, Hospital General de Mexico, Mexico City, presented a study she conducted administering a Spanish version of the Dermatology Life Quality Index to Mexican patients with melasma. The results of that investigation, which also included about 100 patients, showed the quality of life impact of melasma was similar to that previously reported by patients suffering from various other dermatologic diseases, including acne, vitiligo, psoriasis and alopecia. However, it improved by about 50 percent with effective treatment.

New Tri-Luma studies Various members of the PDA have also been involved as investigators in Galderma-sponsored clinical trials of the fixed triple-combination cream containing 4 percent hydroquinone, 0.05 percent tretinoin and 0.01 percent fluocinolone acetonide (Tri-Luma) for the treatment of melasma.

Dr. Cestari presented the results from the Brazilian Tri-Luma study - an investigation mandated by the Brazilian National Ministry of Health to gain marketing approval for Tri-Luma in that country. Conducted in four centers in different areas of the country, it enrolled 120 patients with moderate-to-severe facial melasma who were randomized to treatment with Tri-Luma or hydroquinone 4 percent cream, which was selected according to Ministry regulations as an available active comparator with an approved indication.

The results in the Brazilian study paralleled those observed in the U.S. Food and Drug Administration (FDA) pivotal trials, with 35 percent of patients using Tri-Luma achieving clearing after eight weeks and 73 percent benefiting with a >75 percent improvement. Rates for those outcomes among controls using hydroquinone monotherapy were 5 percent and 49 percent, respectively.

Efficacy data from that trial were used in a pharmacoeconomic evaluation of Tri-Luma presented by Marie-Jose Rueda, M.D, a dermatologist in the Medical Affairs department, Galderma Laboratories, Paris, France. That analysis was done from the patient payer perspective, and calculated the cost per patient cured and the reduction in cost per patient cured with Tri-Luma with comparisons made against the most commonly sold hydroquinone 4 percent product in various markets.

For all countries in which Tri-Luma is now available, the fixed triple combination product was found to be cost-saving. For the Brazilian analysis, the reduction in cost per patient was 52 percent relative to hydroquinone, whereas in the United States, Tri-Luma offered an 84 percent cost savings.